Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Jonathan Goldman, MD (ucla)

Description

Summary

The goal of this interventional clinical trial is to learn about TNG260, a CoREST inhibitor, in combination with pembrolizumab in patients with advanced solid tumors with a known STK11 mutation.

The main question[s] it aims to answer are:

  • the recommended dose for Phase 2
  • to evaluate the safety and tolerability of the combination therapy
  • to determine the pharmacokinetics of TNG260
  • to evaluate the initial antineoplastic activity

Participants will receive study treatment until they experience an undesirable side effect, their disease progresses or until they withdraw consent.

Official Title

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of TNG260 as Single Agent and in Combination With an Anti-PD-1 Antibody In Patients With STK11 Mutated Advanced Solid Tumors

Details

This is a first-in-human Phase 1/2, open-label, multicenter, dose-escalation and expansion study designed to determine the maximum tolerated dose and recommended phase 2 dose(s) and evaluate the safety and tolerability, pharmacokinetics, and antineoplastic activity of escalating oral doses of TNG260 when administered with a standard dose of pembrolizumab in participants with locally advanced or metastatic STK11 mutated solid tumors.

Keywords

Non Small Cell Lung Cancer, Solid Tumors, Adult, Endometrial Cancer, Pancreatic Cancer, Cervical Cancer, Breast Cancer, Carcinoma of Unknown Primary, STK11, KRAS, LKB1, Endometrial Neoplasms, Pembrolizumab, TNG260

Eligibility

You can join if…

Open to people ages 18 years and up

  • Is ≥18 years of age at the time of signature of the main study ICF.
  • Has ECOG performance status of 0 or 1.
  • Has measurable disease based on RECIST v1.1.
  • All participants must have documented STK11 mutation in a solid tumor, which is identified through a validated analytical method
  • Has confirmed histologic or cytologic diagnosis of a locally advanced or metastatic solid tumor.
  • Adequate organ function/reserve per local labs
  • Adequate liver function per local labs
  • Adequate renal function per local labs
  • Negative serum pregnancy test result at screening
  • Written informed consent must be obtained according to local guidelines

You CAN'T join if...

  • Known allergies, hypersensitivity, or intolerance to TNG260, PD-1 antibody or its excipients
  • Uncontrolled intercurrent illness that will limit compliance with the study requirements
  • Active infection requiring systemic therapy
  • Currently participating in or has planned participation in a study of another investigational agent or device
  • Impairment of GI function or disease that may significantly alter the absorption of oral TNG260
  • Active prior or concurrent malignancy.
  • Central nervous system metastases associated with progressive neurological symptoms
  • Current active liver disease from any cause
  • Clinically relevant cardiovascular disease
  • A female patient who is pregnant or lactating

Locations

  • UCLA Hematology/Oncology accepting new patients
    Santa Monica California 90404 United States
  • SCRI at HealthOne accepting new patients
    Denver Colorado 80218 United States

Lead Scientist at University of California Health

  • Jonathan Goldman, MD (ucla)
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 105 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Tango Therapeutics, Inc.
ID
NCT05887492
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 126 study participants
Last Updated